Southwest Rheumatology Research

This trial is not actively recruiting.

This trial has completed recruitment on this platform, and is no longer accepting new referrals.

A clinical trial for rheumatoid arthritis patients.

Study of ATI-450 Plus Methotrexate (MTX) vs MTX Alone in Patients With Moderate to Severe RA

Trial ID: NCT04247815

Clinical trials still provide the safest and -- given the important potential for improving health for millions -- the fastest way to keep medicine moving forward. — Glenn D Braunstein, MD

Trial Details

This is a Phase 2 study to investigate the safety, tolerability, PK, and PD of ATI-450 plus methotrexate versus methotrexate alone in patients with moderate to severe RA.

Estimated Enrollment

25 Participants

Phase

Eligibility Criteria

Participants must:

A male or female between age 18 and 70
Diagnosed with Rheumatoid Arthritis (RA)
Experiencing tenderness and swelling in 4 or more joints
Taking methotrexate to treat your RA (Brand names include Otrexup, Rasuvo, Rheumatrex, and Trexall)

Participants must not:

Chronic liver disease including alcoholic liver disease
History of heart attack, heart failure or chest pain
Active Hepatitis B or Hepatitis C Infection
Previously had a stroke

Key Criteria List

Inclusion Criteria:

Diagnosis of adult-onset RA as defined by the 2010 American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) classification criteria.
DAS28-CRP ≥3.2 defined as moderate to high disease activity.
Have moderately to severely active RA defined by at least 4/28 tender and 4/28 swollen joints.
hsCRP ≥5 mg/L at screening.
Patients must have definitive intra-articular synovitis or osteitis defined as a score of 1 or greater on a Hand-Wrist MRI as assessed by central imaging reader (using RAMRIS).
On a stable MTX dose and a stable dose of folic or folinic acid prior to the screening visit.

Exclusion Criteria:

Patient has a current acute or chronic immunoinflammatory disease other than RA which may impact the course or assessment of RA.
Patient has an uncontrolled non-immunoinflammatory disease that may place the patient at increased risk during the study or impact the interpretation of results.
History or evidence of active or latent tuberculosis.
Active infection requiring treatment with antibiotics.
Blood pressure levels (in supine position after at least 5 minutes rest): <90 mmHg or >140 mmHg for systolic blood pressure or <40 mmHg or >90 mmHg for diastolic blood pressure.
Are currently receiving corticosteroids at doses greater than 10 mg per day of prednisone (or equivalent) or have been receiving an unstable dosing regimen of corticosteroids within 2 weeks of the screening visit.
Have started treatment with non-steroidal anti-inflammatory drugs (NSAIDs) or have been receiving an unstable dosing regimen of NSAIDs within 2 weeks of the screening visit.
Patients with history of stroke.
Any joint procedure in the past 90 days prior to screening.

Commitments from you

You will need to travel to one of the 5 sites taking part in this clinical trial. Sites are located in:

Actively Recruiting

Tampa, Florida, United States

Not yet Recruiting

(Awaiting confirmation) Anniston, Alabama, United States
(Awaiting confirmation) Mesquite, Texas, United States
(Awaiting confirmation) Atlanta, Georgia, United States
(Awaiting confirmation) Duncansville, Pennsylvania, United States

Time

You will be in the study for up to 20 weeks
You will need to visit your designated site 9 times

Study Activities

During the study we will ask you to:

Provide Informed Consent
Have multiple physical exams including assessments of your joints
Have your vital signs regularly assessed
Provide blood samples
Complete MRI assessments
Answer questions about how your disease and general health have been affecting you

Potential Benefits

Treatment in trials is investigational as effectiveness and safety have not been established. There is no guarantee that they will become commercially available.

Potential alleviation of symptoms
Regular health check ups
Help others by contributing to medical knowledge

Frequently Asked Questions (FAQs)

How can I check to see if I am eligible for this trial?

You can check if you are potentially eligible for this trial by completing a set of screening questions. You can find these on this web page by finding the ‘Get Started’ button.

What does a typical research study look like?

Clinical trials help determine the safety and effectiveness of new treatments. A research plan or protocol is created that outlines how trial participants may receive interventions which can include investigational medications, devices, or procedures. The trial may compare a new medical approach to a standard treatment option already available, to a placebo with no active investigational medication, or to no intervention at all. The trial team will share more details before you participate.

Can I stop the trial at anytime?

You can leave the study at any time by telling your study doctor that you no longer want to take part. Your choice will not change the quality of care you receive outside of this study.

Do I get paid for this trial?

Patients receive a fixed per visit stipend of $100.

What personal information is collected about you for the study?

The study doctor and other study staff will collect your personal information. This may include:

Your name, address, telephone number, health insurance number where applicable.
Your age, gender, ethnic and racial background.
Lifestyle information; health and medical history.
Your study treatments and response to study treatments.
Data resulting from testing your biological samples and any images taken.

Who has access to your personal information?

All your personal information collected for this study will be stored in the study medical records at the study site. Sponsor staff, review boards and ethics committees (that approve and monitor studies), and others may check the study records. This is done to make sure that the study is being run properly. Regulatory agencies, such as the US Food and Drug Administration (FDA), European Medicine Agency (EMA) or others, review and approve new medicines. These agencies will be granted direct access to your information. This is so they can verify clinical trial procedures and/or data. If you share your personal data to contact a site, that data will be used by Informa to contact you about clinical trials and related information.